RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs

Inclusion Criteria:

- Male or female subject of any race and at least 18 to 90 years old

- Lower extremity full thickness diabetic foot ulcer of 30-364 days duration

- Subject's wound must be between 2cm² and 20cm² at screening

- Subject's wound must be at or below the malleolus

- Documented ABI is between 0.8 and 1.2 on the study limb or transcutaneous partial
pressure oxygen (TcpO2) > 40 mmHG; or a toe pressure > 40 mmHG; or a Doppler waveform
consistent with adequate flow in the foot (biphasic or triphasic waveforms) within 30
days of screening.

- Subject or subject's legally authorized representative understands the nature of the
procedure(s) and provides written informed consent prior to study enrollment

- Subject is willing and able to comply with all specified care and visit requirements

- Subject and/or caregiver must be willing and able to learn and perform the duties of
dressing changes, and demonstrate the ability to do so.

Exclusion Criteria:

- Index ulcer wound has exposed tendons, ligaments, muscle, or bone

- Index ulcer wound presents with clinical signs of acute infection, suspected or known

- Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb

- Subjects with active Charcot's foot on the study limb

- Subjects with amputation above a Trans Metatarsal Amputation (TMA) in the affected
limb

- Subjects with active malignancy on the study limb except non-melanoma skin cancer

- Subjects with planned vascular surgery, angioplasty or thrombolysis procedures within
the study period

- Subjects within 6 weeks post-operatively of a vascular procedure.

- Subject has had prior skin replacement, negative pressure therapy, or ultrasound
therapy applied to the index wound in the 14 days prior to screening

- Subjects who have received oral, or IV antibiotic/antimicrobial agents or medications
have been used within 2 days (48 hours) of baseline.

- Subjects who have received topical antibiotic/antimicrobial agents or dressings at
the index wound site within 2 days (48 hours) of baseline.

- Subjects currently taking steroids of >10mg dosage

- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma
gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix)
within 14 days of screening date.

- Subject is currently receiving or has received radiation or chemotherapy within 3
months of randomization.

- Subject has one or more medical condition(s), uncontrolled diabetes (HbA1c > 12),
renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the
investigator would make the subject an inappropriate study candidate

- Subject allergic to a broad spectrum of primary & secondary dressing materials,
including occlusive dressings and the adhesives on such dressings.

- Female subjects that are pregnant or refuse to utilize adequate contraceptive methods
and are of childbearing age during the trial.

- Subject is known to be suffering from a disorder or other situation that the subject
or investigator feels would interfere with compliance or other study requirements

- Subject is currently enrolled or has been enrolled in the last 30 days in another
investigational device or drug trial